Trial Identifiers
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Scientific Title
A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Commercial Sponsor
Hoffmann-La Roche
Summary
Eligible patients will be randomised to receive Glofit-GemOx or R-GemOx treatment. Patients randomised to receive Glofit-GemOx, will receive up to 8 cycles of glofitamab (Glofit) in combination with gemcitabine and oxaliplatin (GemOx), followed by up to 4 cycles of glofitamab monotherapy. These patients will also receive a single dose of obinutuzumab 7 days prior to the first dose of glofitamab. Treatment is administered in 21-day cycles. Patients randomised to receive R-GemOx, will receive rituxumab (R) in combination with gemcitabine and oxaliplatin (GemOx) for up to 8 cycles. All treatment will be administered in 21-day cycles.